(88 days)
ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.
ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems.
ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.
The provided text is a 510(k) summary for the ACMI® M4™ Telescope. It indicates that the device is substantially equivalent to a predicate device (ACMI Resectoscope System and accessories, K890328/B) and does not describe a study involving acceptance criteria in the way one might for a novel AI/software-as-a-medical-device.
Therefore, the requested information elements related to such a study (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment) are not applicable to this submission.
Here's an interpretation based on the provided document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Substantial Equivalence) |
|---|---|
| Same intended use as predicate device | "ACMI M4 Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems." (Matches predicate's intended use) |
| Similar technological characteristics to predicate device | "The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices..." |
| Modifications do not significantly affect safety or efficacy | "The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This 510(k) relies on substantial equivalence to a predicate device rather than performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
Explanation:
The K031758 submission is a 510(k) Pre-market Notification for a medical device (telescopes for endoscopy) that establishes substantial equivalence to existing predicate devices. This regulatory pathway primarily focuses on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate, and that any differences do not raise new questions of safety or effectiveness.
It explicitly states: "The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices and, therefore, are substantially equivalent to the ACMI M2 and M3 series telescopes." and "The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Therefore, the submission does not detail a clinical study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it refer to data from test sets, expert consensus, or training sets as would be common for AI/ML-based devices. The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence according to FDA regulations.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.